A Phase II Study of Elotuzumab, Pomalidomide, & Dexamethasone (Elo-Pom-Dex) With Second Autologous Stem Cell Transplantation for Relapsed Multiple Myeloma

Who is this study for? Patients with Multiple Myeloma
What treatments are being studied? Elotuzumab+Pomalidomide+Dexamethasone
Status: Active, not recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Based on the need to improve outcomes post second autologous stem cell transplant (ASCT) for multiple myeloma (MM) and the benefits seen of maintenance treatment following initial ASCT, the natural next step is to evaluate maintenance/continuation therapy following second ASCT. Pomalidomide is active against MM cells refractory to both bortezomib and lenalidomide, making it an ideal choice for continuation therapy following second ASCT. Adding elotuzumab may increase efficacy and also the durability of responses which is essential to improving outcomes following second ASCT.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
View:

• Histologically confirmed diagnosis of multiple myeloma.

• Received prior autologous stem cell transplantation as first line therapy for multiple myeloma with subsequent disease relapse/progression.

• Failed 1 or 2 lines of treatment for multiple myeloma. A line of treatment includes all therapy including induction, transplant, and maintenance administered in a sequence in the absence of relapse/progression. Once relapse/progression occurs and subsequently the anti-myeloma treatment is changed, a new line of treatment has begun. Local radiation or corticosteroids will not be considered treatment for multiple myeloma.

• Received 2 to 6 cycles of induction therapy per standard of care prior to 2nd autologous stem cell transplantation

• Received standard of care melphalan conditioning for 2nd autologous stem cell transplantation, is currently Day +80 to +120 following transplant, and is responding to therapy (partial response or better as compared to pre-induction assessment.

• All US study participants must be registered into the mandatory POMALYST REMS® program and be willing and able to comply with the requirements of the POMALYST REMS® program. For Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program

• Females of reproductive potential within the US must agree to adhere to the scheduled pregnancy testing as required in the POMALYST REMS® program. For Canadian sites, patients will followed according to the Pomalidomide pregnancy prevention program

• At least 18 and no more than 75 years of age at enrollment.

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• Normal bone marrow and organ function as defined as ALL of the following:

• Absolute neutrophil count ≥ 1000/mm^3

• Platelets ≥ 75,000/mm^3 (transfusions not permitted within 7 days of screening)

• Total bilirubin ≤ 2.0 x institutional upper limit of normal (IULN)

• AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN

• Creatinine clearance ≥ 15 mL/min

• Females of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry through Day +100 visit. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

• Able to understand and willing to sign an Institutional Review Board (IRB) approved written informed consent document.

Locations
United States
Colorado
Colorado Blood Cancer Institute (Sarah Cannon)
Denver
Missouri
Washington University School of Medicine
Saint Louis
Other Locations
Canada
University Health Network - Princess Margaret Cancer Centre
Toronto
Time Frame
Start Date: November 22, 2017
Estimated Completion Date: September 26, 2027
Participants
Target number of participants: 25
Treatments
Experimental: Elotuzumab + Pomalidomide + Dexamethasone
Patients will undergo standard of care ASCT melphalan conditioning. Administration of melphalan and the second ASCT will be done as part of routine care and procedures are not dictated by this protocol.~Continuation therapy with Elo-Pom-Dex will begin between Days 80 and 120 following the second ASCT:~Elotuzumab on Days 1 and 15 for Cycles 1-6 followed by 20 mg/kg on Day 1 for Cycles 7+~Pomalidomide daily on Days 1-21 of all cycles~Dexamethasone on Days 1 and 15 of all cycles~Continuation therapy may continue until relapse or progression.
Sponsors
Collaborators: Celgene, Bristol-Myers Squibb
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov

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